Comparison of Patient-reported Pain After Initial Archwire Placement

Not Applicable

Recruiting

• Conditions: Pain, Orofacial; Orthodontic Discomfort
• Interventions: Device: 3M Unitek 0.016 orthodontic archwire

• Registration Number: NCT03906422
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective.

It is possible that one type of wire engenders more patient discomfort. This study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.

Detailed Description

Orthodontic treatment with fixed appliances has the potential to induce pain in patients. At the beginning of treatment, the orthodontist must determine which initial orthodontic archwire to insert. Among the more popular choices for initial leveling and aligning of the dental arches are small-sized, round-diameter nickel-titanium archwires. Various types of nickel-titanium (NiTi) archwires exist including stabilized martensitic wires (ie classic Nitinol), active austenitic wires (superelastic NiTi) and active martensitic wires (thermoelastic NiTi). The efficacy of these wire types has been heavily researched with no significant differences in the alignment timing of the dentition (treatment time to reach the final archwire). Pain differences from these wires has been inconclusive from conflicting past studies. It is of critical importance to determine whether one or more of these archwires leads to more discomfort for the patient than the others.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-08
• Study Start: 2019-05-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Healthy, with no significant systemic diseases or complications or special needs
2. Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
3. All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth).
4. Any planned dental extractions that is part of the orthodontic treatment plan must be carried out at least 3 weeks prior to or after initial orthodontic appliance bonding.
5. Age 12 years or older

Exclusion Criteria

1. Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
2. Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period
3. Metal-type (Nickel) allergies
4. Less than 12 years old
5. Same day use of analgesics prior to bonding
6. Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: 0.016" Nitinol	3M Unitek 0.016 orthodontic archwire	0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.

Primary Outcome Measures

Name	Time	Method
Pain score via Visual Analogue Score	1 hour, 4 hour, 24 hour, 4 day and 7 day	The primary outcome is the change in pain experienced by the study participant over the first week of therapy after insertion of the archwire.; Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line is no pain where the right end is maximum (unimaginable) pain. The specific pain indicated is in the number of millimeters from the left end of the line. This is called the Visual Analogue Score (VAS) where the higher the number the more intense the pain.; The difference in VAS pain scores from the initial VAS after archwire insertion (1 hour) to each measurement time (4 hour, 24 hour, 4 day and 7 day) over 7 days will indicate the change pain experience for each study participant.; For each time point the mean and standard deviation of the change in VAS pain scores for the experimental groups will be calculated and compared for statistically significant differences.

Trial Locations

Locations (1)

University of Colorado School of Dental Medicine; 🇺🇸 Aurora, Colorado, United States